Director of Quality Assurance
AllurionAbout the role
Why Allurion?
We are thrilled to be one of Deloitte's 500 fastest growing technology companies in the US - and now, we are ready to take our success to the next level by going public! This is an incredible opportunity to join our team as a Director of Quality Assurance and help us reach new heights.
At Allurion, our core values of Audacity, Grit, Authenticity, Accountability, and being Data Driven, combined with our passion for innovation, have fueled our growth and will help us achieve our ambitious mission – ending obesity! As part of a recognized Great Place to Work ® in the US, UK, France, Allurions engage as a collaborative global team while solutioning a critical healthcare challenge which affects millions. We are driven by purpose, motivated by individual challenge and growth, and energized by collective engagement and competitive rewards. We invite you to join us as we aim to transform the way obesity is treated and make a lasting impact on the world.
What will you be doing?
As a senior member of our company, the Director of Quality Assurance will play an important role in guiding our company's quality assurance policies and procedures as we continue to expand our operations. As a company committed to making a positive impact on patients' lives, we are looking for an individual who shares our passion to innovate and make a difference. Reporting to the Senior Vice President of Operations, the Director of Quality Assurance will be responsible for ensuring that our medical devices and nutritional programs meet all regulatory and quality standards, from design to manufacturing, supply chain, and distribution.
- Develop, implement, and oversee a strong Quality Management System that meets relevant quality, auditing, and risk standards
- Manage and mentor a team of quality assurance specialists, and maintain a culture of quality in the organization
- Develop and maintain relationships with regulatory agencies, and participate in audits and inspections
- Evaluate all quality systems and continuously improve them for future expansion
- Experience in QMS, Risk Management practices, Corrective and Preventative Actions, Process Validation, and regulatory requirements such as FDA QSRs, CFR 820, ISO 13485, ISO 14971, MDD, and MDR
- Proficiency with statistics, sampling strategies, design of experiments, process capability, including statistical software tools
- At least 8+ years of experience in Quality Assurance in the medical device industry
What’s in it for you:
- Competitive Package
- Paid Time Off
- Training and Career Development
- Global Employee Assistance Program & Total Wellbeing Platform
- Employee Stock Purchase Program
- Benefits and perks are tailored to your country of residence
Location:
Travel:
There is potential for some international travel for company sponsored events.
Hours:
Hours for this role may be flexible and will be communicated to the selected candidate by the Hiring Manager.
Diversity and Inclusion
Allurion is committed to a fair hiring process free from discrimination and we welcome candidates from all backgrounds. If your experience is close (even if not a perfect fit) to what we're looking for, please consider applying. Experience comes in many forms – skills are transferable, and passion goes a long way. We know that diversity makes for the best problem-solving and creative thinking, which is why we're dedicated to adding new perspectives to the team and encourage everyone to apply!
To learn more about Allurion please visit our website
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